# K181670: Alphenix, INFX-8000V/B, V8.0

- Pathway: 510(k) (Traditional)
- Applicant: Canon Medical Systems Corporation
- Decided: Jul 25, 2018 after 30 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K890348 (1989). 32 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172863: Infinix-i, INFX-8000V, V7.0, Toshibamedical Systems Corporation (2017) Summary page 5.

## Most influential descendants
- K203551: Alphenix, INFX-8000V/B, /S, V9.1 (2020), 3 descendants of its own
- K233107: Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5 (2024), 2 descendants of its own
- K251602: Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (2025), 1 descendant of its own
- K253584: Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) (2026), 0 descendants of its own

## Recalls of this device
- Dec 20, 2021 · Class II · Z-0492-2022: Abnormal images such as horizontal stripes may be displayed and recovery may not not be possible by restarting the system. The worst case scenario is an operator who is working without a workable imag

## Indications for use
This device is a digital radiography/fluoroscopy system used in a diagnostic interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

Source page: https://510kreport.com/device/K181670
Methodology: https://510kreport.com/methodology